Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Saline; Drug: Recombinant Human Interleukin-11

Study type: Interventional

Funder types: Other

Identifiers

NCT03720340

IRB-2018-180

Details and patient eligibility

About

Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.

Full description

All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. Oral pharyngeal swabs and stool specimen were collected 3times:before neo-adjuvant chemotherapy,before concurrent chemo-radiotherapy and concurrent chemo-radiotherapy finishied. Patients were randomly divided into two groups randomly. IL-11 was used in experience group and control group, saline.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of nasopharyngeal carcinoma.
2. 8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
3. Age must beetween 18-75.
4. Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
5. Adequate bone marrow, renal, and hepatic function.

Exclusion criteria

1. chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11.
2. Treatment with palliative intent.;Previous malignancy.
3. Pregnancy or lactation.
4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
5. Diabetes, oral mucositis and senile dry stomatitis.
6. Any severe coexisting disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Recombinant human interleukin-11

Active Comparator group

Description:

Mixture of 1.5 mg recombinant human interleukin -11(IL-11) and 10ml 0.9% normal saline(NS) was administered twicely to patients through respiratory tract.

Treatment:

Drug: Recombinant Human Interleukin-11

Drug: Saline

Saline

Placebo Comparator group

Description:

Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.

Treatment:

Drug: Saline